510(k) K864802— DART DIGOXIN ASSAY
Substantially EquivalentCoulter Electronics, Inc.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code LCS
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.